Planed Organ Preservation for Low Rectal Cancer After Neoadjuvant Chemotherapy (OPLAR)
Trial Parameters
Brief Summary
On the basis of our previous study, this project further explored whether patients with effective neoadjuvant chemotherapy can obtain a higher organ preservation rate after total neoadjuvant therapy. This study was designed to enroll patients with low and intermediate-risk rectal cancer. After 2 cycles of XELOX chemotherapy, patients with effective chemotherapy as judged by high-definition MRI of the rectum (the long diameter of the tumor was shortened by ≥30% compared with that before treatment) were randomly divided into two groups. One group was long-course chemoradiotherapy combined with consolidation chemotherapy (TNT group). In the other group, long-term chemoradiotherapy combined with immunotherapy and consolidation chemotherapy (iTNT group), we explored whether TNT could achieve a higher organ preservation rate after effective neoadjuvant chemotherapy in patients with low and intermediate-risk low rectal cancer, and the organ preservation rate of TNT combined with immunotherapy.
Eligibility Criteria
Inclusion Criteria: 1. Age: 18-80 years old; Gender is not limited; 2. rectal adenocarcinoma confirmed by pathology and pMMR/MSS by immunohistochemistry and/or genetic testing; 3. The following characteristics of the tumor were evaluated by thoracoabdominal CT, rectal ultrasound and MRI: ① The distance between the lower edge of the tumor and the anal verge was ≤5cm measured by digital rectal examination or MRI; ② Clinical stage cT1-3abN0-1M0 (if cT1N0, patients suitable for endoscopic resection should be excluded); ③MRF (-) (\> 1mm), EMVI (±); ④ Lateral lymph nodes were negative and less than 7mm; ⑤ tumor diameter ≤5cm; ⑥ tumor circumference ≤2/3. 4. ECOG score: 0-1; 5. Patients with primary rectal cancer did not receive surgery, radiotherapy, chemotherapy or other anti-tumor treatment before enrollment; 6. Normal main organ function, which met the following characteristics: ① Blood routine examination criteria: HB ≥9g/dL, WBC ≥ 3.5/4.0×109/L, neutrophil ≥ 1.5×109/L, PLT≥ 100×109/L; ②